Explorative Assessment of Biomarkers in Overweight and Obese Subjects

Explorative Assessment of Biomarkers Indicative of Insulin Resistance and Prediabetes in Overweight and Obese Subjects

The rationale for this trial is to apply a simple and minimally strenuous pre-screening approach prior to performing more extensive trial-specific screening and baseline-characterization activities in the resulting pre-selected population of subjects.

Study Overview

• Status: Completed
• Conditions: Prediabetes

Detailed Description

The pre-screening assessments are designed to characterize the metabolic risk profile / prediabetic status in an unselected population of overweight and obese volunteers, aiming to pre-select high risk and prediabetic subjects as a target population who may specifically profit from primary diabetes intervention (prevention) strategies.

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Generally healthy or Type 2 Diabetes mellitus

Description

Inclusion Criteria:

• Obese and overweight subjects
• Considered generally healthy

Exclusion Criteria:

• Clinically significant acute illness within 2 weeks before study procedures

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Generally healthy
Type 2 diabetes mellitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anthropometric measures and metabolic biomarkers indicative of prediabetes	One blood sample taken on day 1 of the study	Day one

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intra-subject and inter-subject variability of analyzed biomarkers	Several circulating markers including the traditionally used fasting serum insulin and fasting plasma glucose as well as an oral glucose tolerance test may serve as indicators of prediabetes. Importantly, these parameters show considerable intra-individual short-term variability. The assessments will therefore be repeated three times within a one month period to determine intra-subject variability of the analyzed parameters under the conditions that apply to the trial site and experimental conditions.	within one month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the correlation between anthropometric data, medical history, and biomarkers with regard to metabolic risk	assessment of study data at the end of the study	up to 3 years

Collaborators and Investigators

• Sponsor: Profil Institut für Stoffwechselforschung GmbH
• Investigators: Principal Investigator: Leona Plum-Mörschel, MD, Profil Institut für Stoffwechselforschung GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2013
• Primary Completion (Actual): December 23, 2021
• Study Completion (Actual): December 23, 2021

Study Registration Dates

• First Submitted: July 11, 2013
• First Submitted That Met QC Criteria: July 24, 2013
• First Posted (Estimate): July 29, 2013

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Hyperglycemia; Prediabetic State; Glucose Intolerance; Overweight
• Other Study ID Numbers: OBDM-01